Refitting Daily Disposable Contact Lens Wearers With Dry Eye Disease With A Different Daily Disposable Lens Type

NCT ID: NCT04105842

Last Updated: 2023-07-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-09-23
• Study Completion Date: 2022-07-28

Brief Summary

The purpose of this study is to refit habitual wearers of daily disposable contact lenses who currently experience symptoms of dry eye and discomfort during lens wear with a different type of daily disposable contact lens. Ocular signs and symptoms of dry eye will be assessed following the guidelines outlined by the Tear Film and Ocular Surface Society (TFOS) in the Dry Eye Workshop II (DEWS II). The performance of the habitual contact lenses and the study lenses will be determined using different optometric assessments. Study lenses will be worn for one month following a daily disposable wear schedule.

Conditions

Dry Eye

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Delfilcon A

All study participants will be refit with Delfilcon A (Dailies Total 1) lenses which they will wear for 1 month.

Group Type: EXPERIMENTAL

Delfilcon A

Intervention Type: DEVICE

Participants wear delafilcon A contact lenses on a daily disposable basis.

Interventions

Delfilcon A

Participants wear delafilcon A contact lenses on a daily disposable basis.

Intervention Type: DEVICE

Other Intervention Names

Dailies Total 1

Eligibility Criteria

Inclusion Criteria

1. Is at least 17 years of age and has full legal capacity to volunteer;

2. Has read and signed an information consent letter;

3. Is willing and able to follow instructions and maintain the appointment schedule;

4. As per TFOS DEWS II, have dry eye symptoms (without CL wear) as determined by an OSDI score of ≥13 and at least one of the following:

1. Tear osmolarity ≥ 308mOsm/L or interocular difference >8 mOsm/L

2. Non-invasive tear breakup time of < 10 seconds in at least one eye

3. More than 5 spots of corneal staining OR > 9 conjunctival spots in at least one eye

5. Reports dryness while wearing DD CLs with CLDEQ-8 score ≥ 12 and ≤ 203

6. Habitually wears soft spherical DD CLs with a power between +6.00D and -10.00D

7. Manifest spectacle cyl ≤1.00DC in either eye

8. BCVA ≤0.20 log MAR each eye with habitual & DT1

9. Acceptable fit with habitual & DT1

10. Willing to wear DT1 CLs at least 3 days per week and 6 hours per day throughout the study

Exclusion Criteria

1. Is participating in any concurrent clinical or research study;

2. Has any known active* ocular disease and/or infection;

3. Has a systemic condition that in the opinion of the investigator may affect a study outcome variable;

4. Is using any systemic or topical medications that in the opinion of the investigator may affect a study outcome variable;

5. Has known sensitivity to the diagnostic pharmaceuticals to be used in the study;

6. Is pregnant, lactating or planning a pregnancy at the time of enrolment (by self-report);

7. Is aphakic;

8. Has undergone refractive error surgery;

9. Has taken part in another clinical research study within the last 14 days;

10. Current habitual wearer of DT1

11. Any ocular and/or systemic conditions or concomitant medication to contraindicate contact lens wear or be expected to interfere with the primary outcome variables.

• For the purposes of this study, active ocular disease is defined as infection or inflammation which requires therapeutic treatment. Mild (i.e. not considered clinically relevant) lid abnormalities (blepharitis, meibomian gland dysfunction, papillae), corneal and conjunctival staining and dry eye are not considered active ocular disease. Neovascularization and corneal scars are the result of previous hypoxia, infection or inflammation and are therefore not active.

• Minimum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Alcon Research

INDUSTRY

Sponsor Role: collaborator

University of Waterloo

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Lyndon Jones, PhD, FCOptom

Role: PRINCIPAL_INVESTIGATOR

Centre for Ocular Research & Education

Locations

Centre for Ocular Research & Education

Waterloo, Ontario, Canada

Countries

Canada

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

41251

Identifier Type: -

Identifier Source: org_study_id